In the spirit of the 2014 Winter Olympics in Sochi, I would like to offer a humorous comparison of the rules of aseptic processing and those of hockey (1). Hockey is governed by a three-letter entity called “NHL”; aseptic manufacturing is also governed by a three-letter entity called “FDA”.
In hockey, “Rink Dimensions” refers to the surface area of the game and is predetermined (see Figure 1). In the manufacturing of aseptic products, you also have to predetermine the surface area of manufacturing and decide on the best location and position for each piece of equipment as well as the air flows using fog testing. A hockey rink is surrounded by a wall and glass known as the “Boards and Glass”. The manufacturing environment is also surrounded by walls and glass in order to prohibit outside contamination.
The temperature of the ice surface has to be maintained, providing the optimal “ice” for skating. The temperature where sterile operations occur must also be controlled to decrease microbial growth and provide better work conditions for fully gowned technicians, microbiologists and operators during operations.
“Ice Cleaning” – Aside from the normal ice resurfacing that is performed during the intermission between each period of play, snow removal activities are also performed. In aseptic processing, a thorough cleaning plus additional cleaning during manufacturing operations must be performed.
Figure 1: Hockey Rink (1)
Hockey is a multi-person operation, as is sterile manufacturing. Only people with adequate skills and training are invited to participate. In hockey, you have to limit the number of players on the ice and also in manufacturing environments in order to reduce the risk of contamination. All players are in uniform and the body gear and masks worn by athletes are mandatory and serve to protect them from injury. The uniform of gowns and masks worn by manufacturing personnel is mandatory and serves to limit contamination from outside. Each rink has “Players Benches” and “Changing rooms” for the use of players on both teams. In aseptic manufacturing, a changing room and benches are also provided.
In hockey, there is a restricted area called the “Goal Crease”, which the players have to respect and move in and out of quickly. In manufacturing, the ISO 5 or Class A area near the open vials/ampoules is restricted and operators must go in and out of it quickly. “High sticking” will penalize the player who committed the infraction. If an operator raises her hand over the open glass area, she will be penalized and that portion of the batch may be quarantined for further evaluation.
Picture 2: Goal Dimensions and Crease (1)
In hockey, three periods of 20 minutes limits the time of the game. In the process of manufacturing, we also need to limit the manufacturing time to decrease the risk of exposure to the environment. Each rink is provided with some form of an “Electronic Board” for the purpose of keeping the spectators, players and game officials accurately informed as to all time elements at all stages of the game, including the time remaining, penalties and scores. In aseptic manufacturing, an electronic “Environmental Monitoring software system” is used to keep all levels of the organization informed of the sterility of the environment and the results of viable and non-viable particle counts, gowning monitoring, WFI, purified water and clean steam results, among others.
“Calling a Penalty” – Should an infraction of the rules which would call for a minor or major misconduct, game misconduct or match penalty be committed by a player on the side in possession of the puck, the
Referee shall immediately blow his whistle and penalize the offending player. In aseptic processing, the infraction results in form 483, warning letters and in major citations a consent decree, which ultimately is like being ejected from a game.
Finally, the coaches in the NHL perform extensive results analysis and trending using modern tools to ensure the team has the greatest chance of winning. In aseptic processing, specialists also perform extensive results analysis and trending using adequate “EM Trending software” to ensure the manufacturing is done properly and the current and future risks of product contamination are minimized.
Hockey, like aseptic manufacturing, is a process in which everyone involved endeavors to improve and make gains. Rules must be followed, otherwise the processes will falter, games will be lost and products contaminated.
On behalf of Novatek International www.ntint.com, I would like to congratulate the athletes of the world and wish them great “SUCCESS” in the upcoming Winter Olympics. I would also like to congratulate all the colleagues involved in aseptic processing across the world that ensure all aseptic products are free of contamination.
About the author: Parsa Famili is the President and CEO of Novatek International www.ntint.com and an avid sports enthusiast. He has previously held senior positions in the quality departments of several North American pharmaceuticals. Prior to this he was an instructor of Chemistry and Biochemistry at Vanier College.